Non-invasive Ventilation in Patients With Interstitial Lung Disease - a Feasibility Study

The efficiency of non-invasive ventilation (NIV) in hypercapnic patients with chronic obstructive pulmonary disease during pulmonary rehabilitation has been shown in numerous studies. There is only a limited number of therapeutic options for patients with severely progressed interstitial lung disease (ILD). The question whether chronic hypercapnic ILD-patients are able to profit from nocturnal NIV and thus increase their performance in physical training has been left unknown. Therefore, this study aims to evaluate the feasibility of the initialization of a NIV for hypercapnic ILD-patients during pulmonary rehabilitation.

Study Overview

• Status: Unknown
• Conditions: Lung Diseases, Interstitial; Noninvasive Ventilation
• Intervention / Treatment: Other: non-invasive ventilation

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Klaus Kenn, MD; Phone Number: 1540 0049865293; Email: KKenn@Schoen-Kliniken.de
• Study Contact Backup: Name: Rainer Gloeckl, PhD; Phone Number: 1630 0049865293; Email: rgloeckl@schoen-kliniken.de

Study Locations

• Germany
  • Bayern
    • Schoenau Am Koenigssee, Bayern, Germany, 83471
      • Recruiting
      • Schoen Klinik Berchtesgadener Land
      • Contact: Klaus Kenn, MD; Phone Number: 1540 0049865293; Email: KKenn@Schoen-Kliniken.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• confirmed diagnosis of Interstitial lung disease
• Hypercapnia defined as carbon dioxide partial pressure ≥45 mmHg (at rest, night or activity)
• already existing but not sufficient and regular use of non-invasive ventilation (≤3h/24h)
• patients consent to participate in this trial

Exclusion Criteria:

• acute pulmonary insufficiency (ph<7.35)
• acute, clinically relevant heart disease
• already existing and sufficient use of non-invasive ventilation (≥3h/24h)
• Body-Mass-Index>30
• obstructive sleep apnea
• Intolerance to perform non-invasive ventilation
• acute infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: non-invasive ventilation; patients will undergo about 14 nights of non-invasive ventilation during pulmonary rehabilitation	Other: non-invasive ventilation; patients will undergo a nocturnal non-invasive ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
timespan until sufficient use of noninvasive ventilation > 6h during night	day 4-16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-minute walking test	change in 6-minute walking distance	day 1-3 and day 17-19
arterial pressure of carbon dioxide during night	measured transcutaneously by a Sentec device	day 1-3 and day 17-19
lung function measured by bodyplethysmograph	measured by bodyplethysmograph	day 1-3 and 17-19
energy expenditure during night assessed by Sensewear Armband	assessed by Sensewear Armband	day 5 and 15
quality of life	Short-Form-36 health survey, Hospital Anxiety and Depression scale and severe respiratory insufficiency questionnaire	day 1-3 and 17-19

Collaborators and Investigators

• Sponsor: Schön Klinik Berchtesgadener Land
• Collaborators: Weinmann Geräte für Medizin GmbH + Co. KG
• Investigators: Principal Investigator: Klaus Kenn, MD, Schoen Klinik Berchtesgadener Land

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: February 26, 2015
• First Submitted That Met QC Criteria: March 3, 2015
• First Posted (Estimate): March 4, 2015

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: NIV-ILD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No